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Effects of Treatment on Decision-making in Major Depression

19 de octubre de 2017 actualizado por: Boadie W. Dunlop, Emory University
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

During episodes of depression patients with major depressive disorder (MDD) may make sub-optimal decisions based on exaggerated negative beliefs about themselves, the future, or the world around them. These disruptions in decision-making contribute adversely to quality of life, in both work and personal realms. Although effective treatments for depression are available, very little work has explored the effects of treatment on how people make decisions. The specific aspects of decision-making that differ between depressed and health control individuals are unknown, and whether any changes in these decision-making features occur as a result of improvement from depression, or whether medication treatment itself can lead to changes in decision-making, even in the absence of clinical improvement.

In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.

The overall goal of this study will be to identify whether decision-making characteristics in people with major depression is affected by treatment, and whether depressed patients make decisions differently from healthy controls. A total of 4 decision-making tasks and one control task will be administered via computer to eligible subjects. The specific tasks are:

  1. Risk Task - This task assesses tolerance of risk by having participants decide whether they wish to accept a specific dollar payout, or to play a lottery with an uncertain payout.
  2. Balloon Analogue Risk Task - The participant is presented with a balloon and offered the chance to earn money by pumping the balloon up by clicking a button. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes. Thus, each pump confers greater risk but also greater potential reward. If the participant chooses to cash-out prior to the balloon exploding then they collect the money earned for that trial, but if balloon explodes earnings for that trial are lost. Participants are not informed about the balloons breakpoints; the absence of this information allows for testing both participants' initial responses to the task and changes in responding as they gain experience with the task contingencies.
  3. Temporal Discounting Task - Participants are initially asked to choose between taking an immediate reward now or a larger reward at some time in the future. Decisions for seven time points over a 10-year time frame are proposed. The task is then repeated using choices between immediate and delayed losses, based on the same seven time points. This task assesses the manner in which subjects value immediate outcomes compared to long-term consequences.
  4. Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm commonly employed in behavioral economics to measure emotional reactions to unfair offers. In the UG, two subjects sequentially exchange real monetary amounts. Specifically, a proposer is provided with a sum of money by the experimenter ($10), and asked to share this amount of money with another player, the responder. The responder then decides whether to accept or reject the offer made by the proposer. If the responder accepts the offer, both players receive the respective amounts from the proposer's offer. If she rejects the offer made by the proposer, both players receive nothing ($0). This is best illustrated via the following two potential scenarios: 1. the proposer offers a fair split of $5 for himself and $5 for the responder. This is an offer that is typically accepted by a great majority of responders. 2. The proposer offers a split of $9 for himself and $1 for the responder. Such offers are commonly rejected by the majority of responders, despite incurring a financial loss of $1.
  5. Continuous Performance Task - This task involves identifying patterns of numbers briefly displayed on a computer screen. This task will serve as a control variable for attention in analyzing the results of the decision-making tasks.

Tipo de estudio

Intervencionista

Inscripción (Actual)

53

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory Mood and Anxiety Disorders Program

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria for MDD Subjects:

  1. Male or female, age 18-65
  2. Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
  3. Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.
  4. Ability to visually read and understand English language
  5. Not currently taking an antidepressant.
  6. Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.

Inclusion Criteria for Healthy Control Subjects:

  1. Male or female, age 18-65
  2. No current DSM-IV TR diagnosis of a mental illness.
  3. No lifetime history of Major Depressive Disorder or Dysthymia.
  4. Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.
  5. Ability to visually read and understand English language
  6. Not currently taking any psychoactive medication

Exclusion Criteria for all subjects:

  1. Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
  2. Meet criteria for substance abuse or dependence within three months of the screening visit.
  3. Presents with a clinically significant suicide risk, as assessed by a study physician.
  4. Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
  5. Women who are currently pregnant or lactating, or plan to become pregnant during the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Participants with Major Depressive Disorder
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.
Otros nombres:
  • Sertraline, Zoloft
  • Citalopram, Celexa
  • Escitalopram, Lexapro
  • Paroxetine, Paxil
  • Fluoxetine, Prozac
  • Vilazodone, Viibryd
  • Venlafaxine XR, Effexor XR
  • Desvenlafaxine, Pristiq
  • Duloxetine, Cymbalta
  • Bupropion, Wellbutrin
  • Mirtazapine, Remeron
Sin intervención: Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Money Earned
Periodo de tiempo: Baseline, Week 6

Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making.

The specific tasks were:

  1. risk task
  2. balloon analogue risk task
  3. temporal discounting task
  4. ultimatum game
  5. continuous performance task
Baseline, Week 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2013

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2013

Primero enviado que cumplió con los criterios de control de calidad

3 de agosto de 2013

Publicado por primera vez (Estimar)

6 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de noviembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

19 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00066705

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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